Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)

  • STATUS
    Recruiting
  • End date
    Sep 28, 2024
  • participants needed
    1542
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 5 May 2021
cancer
measurable disease
fluorouracil
oxaliplatin
capecitabine
pembrolizumab
HER2
EGFR
human epidermal growth factor
cancer chemotherapy
adenocarcinoma
erbb2
mk-3475

Summary

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants.

The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).

Details
Condition Gastropathy, Gastric Cancer, Stomach Discomfort, Stomach Cancer, gastric neoplasm, gastric tumor
Treatment Capecitabine, cisplatin, Pembrolizumab, Oxaliplatin, 5-fluorouracil, Placebo for Pembrolizumab
Clinical Study IdentifierNCT03675737
SponsorMerck Sharp & Dohme Corp.
Last Modified on5 May 2021

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